Search FDA 510(k) Devices

5,395 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
385–408 of 3,225
Cleared Nov 19, 2025
OptiPAP Junior Flexi Tube US (OPTIPAPFUS)
K250651 · SGR
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 260d
Cleared Nov 19, 2025
LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
K250642 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 260d
Cleared Nov 19, 2025
MyPAO SA guides
K242603 · PBF
Medacta International S.A.
Orthopedic · 446d
Cleared Nov 18, 2025
ToeJack MIS Bunion System
K253423 · HRS
Nvision Biomedical Technologies, Inc.
Orthopedic · 54d
Cleared Nov 18, 2025
Miniature Telescope for Urology (27033AA)
K253411 · FGB
Karl Storz SE & CO. KG
Gastroenterology & Urology · 49d
Cleared Nov 18, 2025
Dexcom Smart Basal
K252818 · QRX
Dexcom, Inc.
Chemistry · 75d
Cleared Nov 18, 2025
Universal Spinal System
K252729 · NKB
Double Medical Technology, Inc.
Orthopedic · 82d
Cleared Nov 18, 2025
Fluido Compact System
K252636 · LGZ
The Surgical Company International B.V.
General Hospital · 90d
Cleared Nov 18, 2025
Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant...
K252582 · NHA
Prismatik Dentalcraft, Inc.
Dental · 95d
Cleared Nov 18, 2025
SAFElife T-Cup Multi-Drug Urine Test Cup
K252550 · NFT
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 97d
Cleared Nov 18, 2025
LifeStyles® HydraFeel Natural Rubber Latex Condom
K252521 · HIS
Suretex Limited
Obstetrics & Gynecology · 99d
Cleared Nov 18, 2025
ulricheasyINJECT Max 2M (XD 10140)
K252281 · IZQ
Ulrich GmbH & Co. KG
General Hospital · 119d
Cleared Nov 18, 2025
Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06)
K251695 · DQA
Unimed Medical Supplies, Inc.
Anesthesiology · 169d
Cleared Nov 18, 2025
Unimed Reusable SpO2 Sensors (-75 Series) (U410-75)
K251693 · DQA
Unimed Medical Supplies, Inc.
Anesthesiology · 169d
Cleared Nov 18, 2025
Collagen Dura Regeneration Membrane - Repair
K251191 · GXQ
Collagen Matrix, Inc.
Neurology · 215d
Cleared Nov 18, 2025
Hexoskin Medical System (7100-00016)
K243981 · DXH
Carre Technologies, Inc.
Cardiovascular · 330d
Cleared Nov 17, 2025
ACUSON Maple Diagnostic Ultrasound System
K253487 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Nov 17, 2025
PM2™ System with ECGuide™ Connector
K252792 · LJS
Piccolo Medical, Inc.
Cardiovascular · 76d
Cleared Nov 17, 2025
DeepRESP
K252330 · OLZ
Nox Medical Ehf
Neurology · 115d
Cleared Nov 17, 2025
DTX Studio Assist
K252086 · MYN
Nobel Biocare C/O Medicim NV
Radiology · 138d
Cleared Nov 17, 2025
TS-RF Generator (STS10)
K251566 · GEI
Starmed Co., Ltd.
General & Plastic Surgery · 179d
Cleared Nov 17, 2025
Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile...
K251141 · LZA
Mercator Medical (Thailand), Ltd.
General Hospital · 217d
Cleared Nov 17, 2025
Access Rubella IgG
K250588 · LFX
Beckman Coulter, Inc.
Microbiology · 263d
Cleared Nov 14, 2025
Lyme-ID IgG Test
K252627 · LSR
Inanovate, Inc.
Microbiology · 86d